When compared to the general population, patients with Type 2 diabetes are at increased risk of developing numerous other health problems, including heart disease, cancer, and pancreatitis.
Type 2 diabetics have a 2-fold to 4-fold greater risk of developing coronary heart disease than the general population. Haffner, The Journal of Clinical Endocrinology & Metabolism, 85(6):2108-2110 (2000). Type 2 diabetics are also at increased risk of developing twenty-four different types of cancer including cancers of the pancreas, liver, kidneys, thyroid, esophagus, small intestine, and nervous system. For example, Type 2 diabetics have a 6-fold greater risk and a 4.25-fold greater risk of developing pancreatic cancer and liver cancer, respectively, when compared to the general population. German Cancer Research Center Press Release dated May 20, 2010.
Type 2 diabetics have a 2.8-fold greater risk of developing pancreatitis when compared to the general population. Noel et al., “Increased Risk of Acute Pancreatitis and Biliary Disease Observed in Patients With Type 2 Diabetes,” Diabetes Care, 32(5):834-838 (2009). Pinhas-Hamiel et al., “Acute necrotizing pancreatitis in an adolescent with type 2 diabetes,” Current Opinion in Pediatrics, 18(2):206-208 (2006). The severity of pancreatitis can vary from a mild form to life threatening multiple-organ failure.
Numerous classes of drugs are used to treat Type 2 diabetes, including GLP-1 receptor agonists, such as exenatide (commercially available as BYETTA® from Amylin Pharmaceuticals, Inc. and Eli Lilly and Company). Despite the increased risk of pancreatitis in diabetic patients, the FDA issued an alert in October 2007 of a suspected association between BYETTA® and acute pancreatitis following a review of thirty post-marketing reports of acute pancreatitis in type 2 diabetic patients taking BYETTA®. In view of this FDA alert, studies were undertaken to determine what relationship, if any, existed between pancreatitis and GLP-1 receptor agonist compounds, such as exenatide.
The disclosure is directed to the findings that GLP-1 receptor agonists do not cause pancreatitis, but can actually be useful to treat pancreatitis.